When I first stepped into the startup world, my focus was purely on product development—turning great ideas into working medical devices. But I quickly realized that without regulatory clearance, even the best innovations go nowhere.
Thrown into the deep end, I had to learn the FDA 510(k) process fast—and get it right. Through real trial and error, I developed a streamlined approach that’s helped me bring multiple devices to market successfully.
This course shares everything I wish I had when starting out:
✅ Real submission examples
✅ Downloadable templates
✅ A practical, no-fluff process from start to finish
If you're building a Class II medical device and want to skip the confusion, this course is for you.
Course curriculum
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1First Section